System for determining the position of a knee prosthesis

ABSTRACT

The present application provides an apparatus arid method for determining a position of a joint prosthesis using a computer assisted orthopedic surgery system in support of an arthroplasty surgery. The apparatus and method includes attaching a first beatable element to a first bone on one side of a joint, providing a sensor having a second beatable element and moving the sensor in proximity of the joint to locate a plurality of positions of the sensor relative to the first beatable element using a tracking device. The apparatus and method further includes selecting a generic model of a joint determining the generic model in response to the plurality of positions located using the tracking device to generate a deformed model, determining a position for a joint prosthesis on the deformed model and outputting on a display the determined position, upon the deformed model.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/404,358 filed Feb. 24, 2012, which is a continuation of U.S. patentapplication Ser. No. 10/415,962 filed Oct. 22, 2003, now U.S. Pat. No.8,126,533, which is a 371 national phase of International ApplicationNo. PCT/FRO1/03423 filed Nov. 6, 2001, which is entitled to and claimsthe benefit of foreign priority under 35 U.S.C, § 119 to French PatentApplication No. 00/14173, filed Nov. 6, 2000, the entire disclosures ofwhich ate hereby incorporated herein by reference.

The present invention relates to a system for determining the positionof a prosthesis enabling assisting a surgeon in the fitting of kneeprostheses, by means of the computer system present at the operatingsuite.

The general aim of computer-assisted knee surgery is to determine anoptimal position of the prostheses on the tibia, on the femur, andpossibly on the patella according to geometric and dynamic criteria, andto provide devices enabling effective placing of the prostheses at theoptimal place, ideally, an alignment of the centers of the hip, of theknee and of the ankle is attempted to be restored for a knee placed inextension, while balancing the position of the patella and the tensionsof the ligaments in a flexional motion, and while having goodadjustments of the prostheses with the bones. In some cases, only aportion of the knee is replaced, for example, one of the two condyles ofthe femur, but the criteria remain identical.

Conventional methods use mechanical ancillaries adjustable according tothe radiological data of each patient. Such methods are inaccurate anddo not enable performing an ideal prosthesis fit in ail cases, whichsometimes leads the surgeon to progressively adjusting the positions ofthe prostheses, which is long and difficult, or to be content with anaverage quality result.

To overcome these disadvantages, computer-assisted surgery systems usingposition sensors, computers and possibly robots have been developed.

Generally, in conventional computer-assisted surgery systems, aremarkable element, also known as the measurement mark, to a bone or ananatomic structure and its motions are followed by means of a positionsensor, also known as a locating system or a tridimensional positioningsystem. Such a position sensor may be a set of cameras which locate theposition and orientation of measurement marks, each formed, of at leastthree infrared diodes or reflective markers. Many acoustic, mechanical,or magnetic technologies enabling locating of the relative position andorientation of two position marks attached on anatomic structures,surgical instruments, digitizing palpation devices or various sensorssuch as described in chapter 1 of hook “Computer Integrated Surgery”,MIT Press, 1996, R. Taylor ed., entitled “Multimodal Information forComputer-Integrated Surgery”, pages 5-21, by R. Moesges and S. Lavalleemay be used. One of the position marks may also be used as a positionsensor, as is the case in small-size magnetic systems. By means of theseposition sensors, a palpation device may be used to digitize points onthe surface of the structures equipped with a position mark, and motionsbetween two bones equipped with position marks may also be recorded.

Most of the existing computer-assisted surgical systems for assistingthe fitting of a total knee prosthesis require use of medical imagesacquired before m intervention by powerful means such as thetomodensimetric (TDM) scanner or magnetic resonance imaging (MRI), asdescribed in the patents of ORTHOSOFT Inc. (WO 99/60939), Eric Brosseauet al., or of Scott Delp et al. (U.S. Pat. No. 5,682,886). Based onthese images, a doctor can plan and partially simulate a surgicalintervention, then complex techniques of adjustment between thepatient's images and the patient's position on the operation tableenable following and reproducing the planned strategies. However, theacquisition of such images in clinical routine is complicated to manage,it has a non-negligible cost, error risks are associated with theadjustment methods, and the use of a scanner generates an X-ray dosewhich is non-negligible for the patient. Further, such systems do notuse the cinematic and dynamic information which can be easily acquiredat the beginning of an operation, they thus do not enable directly andeasily obtaining the ideal position of the prosthesis.

An alternative consists of only using information acquired just beforethe beginning of the operation by means of position sensors. Suchmethods are however limited in their use since they only enablecollecting very simple information to remain within reasonable timelimits.

In this category, the most widely used methods are based on the searchfor an alignment of the three rotation centers of the knee, of the hip,and of the tibia, as described for example in documents WO-A-95/00075 ofANDRONIC and WO-A-98/40037 of AESCULAP. However, in such methods, thedetermination of the knee center is made difficult and inaccurate by thestrong anatomic variations of each knee, which must undergo anintervention, the very definition of a pathological knee being thesubject of debates and controversies.

The present invention aims at using a simple equipment including acomputer, a screen, a tridimensional positioning system, a positionmark, attached an each bone of the joint, and a position mark placed ona drilling guide.

An object of the present invention is to provide an automatic system fordetermining the best size, position and orientation for each implantlaid on one or several osseous section planes, such as a conventional,tibia and femur prosthesis.

Another object of the present invention is to provide such a system inwhich the complete surface of each bone is obtained by deformation of ageneric model at the operating suite, without MRI or TDM images.

Another object of the present invention is to provide such a system inwhich the degree of accuracy at any point of the image of the bonesurface is indicated by a color.

Another object of the present invention is to provide such a system inwhich ligamentary information are taken into account to balance thetensions between each bone of the knee joint.

Another object of the present invention is to provide such a system inwhich a drilling guide particularly simple to place to then ensure theaccurate positioning of a section guide is provided.

An advantage of the present invention is that it enables avoidingdetermination of a knee center on the patient. Instead of aligning anycenter of the pathological knee with the center of the hip and of theankle, the present invention provides aligning the center of theprosthesis of the pathological knee with the center of the hip and ofthe ankle.

Another advantage of the present invention is that it enablesautomatically determining an ideal theoretical position of all theimplants to be attached on each bone, taking into account all theessential criteria and then letting the surgeon modify the parameterswith respect to the so-called ideal, reference, just before performingthe surgical acts enabling placing the implants.

Another advantage of the present invention is that it no longer needsall the TDM or MRI methods of medical image acquisition and adjustment.

To achieve these objects, the present invention provides a system fordetermining the ideal theoretical position of a knee prosthesisincluding, for the determination of the position of a tibial prosthesis,means for:

-   -   determining the shape of the proximal portion of the tibia and        its position with respect to the center of the ankle joint;    -   determining a high point of the superior surface of the tibia;    -   calculating the position, the orientation, and the size with        respect to the tibia of the tibial prosthesis and of the section        plane corresponding to the tibial prosthesis, taking the        following parameters into account:    -   the perpendicular to the section plane crossing the center of        the prosthesis also crosses the center of the ankle joint,    -   the section plane is at a distance from said high point equal to        the height of the prosthesis to be attached,    -   the large side of the prosthesis is centered on the large side        of the section of the tibia in the section plane,    -   the anterior edge of the small side of the prosthesis is at a        predetermined distance from the anterior edge of the small, side        of the tibia section in the section plane; and    -   determining the orientation in the section plane of the        prosthesis so that the large side of the prosthesis is parallel        to the horizontal axis of the knee.

According to an embodiment of the present invention, the system furtherincludes, to determine the position of a femoral prosthesis, means for:

-   -   determining the relative position of the distal portion of the        femur with respect to the center of the hip joint;    -   calculating the position, the orientation and the size with        respect to the femur of the femoral prosthesis and of the        section plane corresponding to the femoral prosthesis, taking        the following parameters into account:    -   the perpendicular to the section plane crossing the center of        the prosthesis also crosses the center of the hip joint,    -   the distal section plane is at a distance from the most distal        point on one of the condyles equal to the thickness of the        prosthesis to be attached,    -   the posterior section plane is at a distance from the most        posterior point on one of the condyles equal to the thickness of        the prosthesis to be attached,    -   the large side of the prosthesis is centered on the large side        of the section of the femur in the section plane,    -   the maximum size of the prosthesis is such that the edge of the        prosthesis is as close as possible hot inside of the femur        surface; and    -   determining the orientation in the section plane of the        prosthesis so that the large side of the prosthesis is parallel        to the horizontal axis of the knee.

According to an embodiment of the present invention, the orientation andthe lateral position of the femoral prosthesis are adjusted, with analignment of the plane of the trochlea of the femoral prosthesis withthe trajectory of the center of the digitized patella during a kneeflexion motion, by means of a position mark placed on the externalsurface of the patella.

According to an embodiment of the present invention, this system furtherincludes, to determine the shapes and positions of the tibia, of thefemur, of the center of the ankle joint and of the center of the hipjoint:

-   -   elements beatable in position in a tridimensional positioning        system, attachable at least to the tibia and to the femur,    -   a palpation device, an echographic device, and/or a radiographic        device to locate in said tridimensional positioning system the        position of various points of the tibia and. of the femur with        respect to said beatable elements, and    -   means for adjusting a preestablished model of the leg bones by        using the collected position information.

According to an embodiment of the present invention, said model alsoincludes a modeling of the positions of the attachments of the ligamentsof the knee joint, this modeling being adapted to the patient at thesame time as the model of the bone surface, and said model also includesthe values of the maximum elongations of each ligament, experimentallydetermined by having the still non-operated patient's leg move to locatethe displacement limits linked to existing ligaments.

According to an embodiment of the present invention, the system furtherincludes means for:

-   -   simulating on the image of the femur-tibia assembly the        positioning of the prostheses linked together for different        flexion positions, and the position of the knee ligaments;    -   deducing therefrom the motion limits that the leg provided with        the prosthesis will have with the existing ligaments; and    -   taking this information into account to modify the theoretical        ideal position of the knee prosthesis, and/or to suggest an        intervention on the ligaments.

According to an embodiment of the present invention, said palpationdevice has a ballshaped end and the locating by the palpation device isperformed dynamically as said bail is displaced against the portion tobe analyzed, the tridimensional positioning system being designed todetermine the instantaneous positions of the bail center and a system ofsurface reconstitution from a deformable model being designed to performa correction corresponding to the ball radius.

According to an embodiment of the present invention, an image of theadjusted model is formed and this image is displayed by assigning itsvarious areas colors or thicknesses characterizing the density of pointsfound in this area by the palpation device, which indicates the degreeof accuracy of the model of the corresponding area.

According to an embodiment of the present invention, the system includesmeans for:

-   -   determining by calculation locations at which the tibia/femur        must be drilled into to accommodate a section guide;    -   pointing these locations cm the displayed image of the        tibia/femur,    -   permanently displaying on the restored image of the tibia/femur        the image of a drilling guide provided with locating means in        said tridimensional positioning system, this guide including        tubes separated by the same interval as tubes of the section        guide intended to be assembled on threads fixed in the bone,    -   and the drilling guide includes a central point that can bear        against the bone and the image of which must coincide with a        target point pre-positioned on the displayed image of the        tibia/femur.

According to an embodiment of the present invention, the drilling guidefurther includes adjustment means, operable once the guide has beenbrought to its position.

According to an embodiment of the present invention, the locatableelements respectively associated with the tibia, with the femur and withthe sensor are geometrically differentiated.

According to an embodiment of the present invention, the beatableelement associated with the tibia has the shape of letter T, thelocatable element associated with the femur has the shape of letter F,the locatable element associated with the palpation device has the shapeof letter P.

According to an embodiment of the present invention, the position of thepatella component of the prosthesis is obtained by means for:

-   -   determining in a tridimensional positioning system the        trajectory of an element having a locatable position attached to        the external surface of the patella in a knee flexion motion,    -   determining the point of the internal patella surface which        better coincides with the center of the groove of the prosthesis        of the femur for a selected angular flexion area;    -   guiding the placing of a drilling thread towards said point.

The foregoing objects, features and advantages of the present inventionwill be discussed in detail in the following non-limiting description ofspecific embodiments in connection with the accompanying drawings.

FIGS. 1A and 1B show a front view and a side view of a femur-tibiaassembly;

FIGS. 2A and 2B illustrate a femur and an associated sensor;

FIGS. 3A and 3B show a distal end portion of a femur and colored areasthereon;

FIG. 4 shows a model of a femur-tibia assembly and of associatedligaments;

FIGS 5A to 5C illustrate the assembly of a prosthesis according to thepresent invention;

FIGS. 6A to 6C illustrate steps implemented by the system according tothe present invention;

FIG. 7 shows a drilling tool according to the present invention;

FIG. 8 shows targets for determining the position of a drilling objectaccording to the present invention;

FIG. 9 shows an alternative of the drilling tool according to thepresent invention;

FIG. 10 shows another alternative of the drilling tool according to thepresent invention; and

FIG. 11 shows another alternative of the drilling tool according to thepresent invention.

To perform an intervention according to the present invention, the bonesare placed in the field of a tridimensional positioning system. Then, asillustrated in FIG. 1A in side view and in FIG. 1B in front view,elements locatable by the tridimensional positioning system respectivelyattached on femur 1 and on tibia 2 of a patient, respectively 3 and 4,are analyzed. These locatable elements are generally points screwed inthe bones, one end of which is provided with markers which may bereflective disks, reflective spheres, or infrared diodes. As illustratedin FIG. 2A, to avoid any error risk, the present invention provides forlocatable element 3 attached on the femur to be F-shaped, with at leastthree markers attached on the ends of the branches and on the corners ofthe F. This device enables having the largest possible letter, whichavoids any possible contusion, with markers which are as distant aspossible, which increases the system accuracy, while forming a compactshape. Similarly, the locatable element attached to the tibia isT-shaped with three markers attached to the ends of the branches of theT. All locatable elements may thus be associated with a letter, P forthe palpation device, R for the patella, H for the humerus, etc.containing markers on the ends of its branches and on its corners.

Reference number 3 designates the center of rotation of the hip betweenthe femur and the ilium, reference number 6 designates the center of theankle between the tibia and the foot, and reference number 7 designatesthe joint of the knee between the femur and the tibia, in FIG. 1B, thepatella has been designated with reference number 8 and a locatableelement attached to the patella on its external surface has beendesignated with reference number 9.

The present invention provides using means for determining thedeformation of a generic model to follow digitized points on the realbone. The model is generally formed of a set of several hundreds oftriangular facets connected to one another on their edges and vertexes.Methods may be used, which are described in chapter 16 of book “BrainWarping”, Toga ed., Academic Press, 1999, entitled “Elastic registrationand Interference using Oct-Tree Splines”, pages 282-296, S. Lavallee etal., consisting of deforming as little as possible a volume meshingwhich encompasses and drives along the digitized surface points to havethem coincide with the model surface, then inverting the transformationfunction thus obtained to deform the generic model towards the digitizedpoints. In such a method, it is first searched for a general deformationwhich brings some specific anatomic points palpated by the user to theirhomologous points of the model, after which the deformation is refinedby progressively decreasing the sum of the squares of the distancesbetween all the palpated points and the model surface. Methods ofdistance calculation between points and a surface represented bytriangular facets are widely known in computerized tridimensionalgeometry literature. A deformation function F transforming thecoordinates (X,Y,Z) of a point expressed in the position referencesystem into coordinates (X′, Y′, Z′) of the point expressed in areference system associated with the model is thus obtained. To obtainthe deformed model, the antecedent point (X,Y,Z) of each point of themodel (XM,YM,ZM) over function F is searched by iteratively minimizingthe interval between (XM,YM,ZM) and F(X,Y,Z) and the geometric linksapplied between the model points. Methods described in article “Buildinga complete surface model from sparse data using statistical shapemodels: application to computer assisted knee surgery” by M. Fleute andS. Lavallee, published in Medical Image Computing And Computer-AssistedIntervention—MICCAI '98, Spinger-Veriag LNCS Series, pages 880-887,October 1998 may also be used. Such methods are robust since they usestatistical models. An intelligent interpolation of the points enablingconstructing complex surfaces by means of a few points, and thus easilyand rapidly, is then achieved. The two mentioned approaches may also becombined by starting with searching for the deformation of a statisticalmodel according to the method described in Fleute's previously-mentionedarticle, then by carrying on with a deformation of a volume meshingaccording to the method described in S. Lavallee's article published inpreviously-mentioned book “Brain Warping”.

To determine and digitize points on the bone surface, a palpation devicelocatable in the tridimensional positioning system is used.Conventionally, a palpation device with a pointed end may be used toobtain points on the surface with a good accuracy, but such a palpationdevice clings onto the bone and it is difficult to digitize many pointson the fly.

The present invention provides, as illustrated in FIGS. 2A and 2B, usinga sensor 10 having its end in contact with the area to be detectedincluding a specific portion with a radius that can be greater than 0.5mm (preferably, from 0.5 mm to 3 mm). From a time when the surgeon oranother operator sends an order by a pressure on a foot or hand control,or by voice control, many points can then be digitized on the fly bysliding the spherical portion on the bone surface, but points shifted bya value equal to the radius of the sphere outside of the real surfaceare recorded. This shifting will have to be compensated for. Tocompensate for the sensor sphere radius, the present invention providesmeans for progressively minimizing the sum of the distances between eachpoint and the model surface to which the value of the sensor radius issubtracted provided that the distances to the surface are positiveoutside of the surface and negative inside of the surface.

Despite the use of the sphere, it would be tedious to ask the operatorto digitize all the useful parts of the bone surface. This may require asignificant manual work and the reconstructed surfaces may be quiteinaccurate, or even erroneous.

In cases where the surface points cannot be directly accessed to, anechographic probe equipped with a position mark may be used to locatepoints on the bone through the skin, as described in chapter 32 of book“Computer Integrated Surgery”, MIT Press, 1996, R. Taylor ed., entitled“Computer-assisted spinal surgery using anatomy-based registration”,pages 434-437, by S, Lavallee et al. The surface may also be constructedby using a few radiographic images obtained at the operating theatresuite or in the radiology room. If radiographs acquired outside of theoperating suite are used, the models thus reconstructed must then beadjusted on the operating data. Such techniques are described in article“Nonrigid 3D/2D registration of images using statistical models” by MRente and S, Lavallee, published in Medical Image Computing AndComputer-Assisted Intervention—MICCAI '99, Spinger-Verlag LNCS Series1679, pages 138-147, October 1999, This article also describes how tocombine radiological information and position information to construct3D surfaces.

The surface reconstructed by the deformation method cannot be perfectand inaccuracies remain, especially in regions where points have notbeen palpated. It is important for the surgeon to be informed of theinaccuracies of the surface reconstruction. As illustrated in FIG. 3A,to give an indication of this inaccuracy to the surgeon, the presentinvention provides displaying on a screen of the computer the surfacesreconstructed in 3 dimensions with surface colorings according to theestimated inaccuracy. For example, in regions 21, which are critical forthe prosthesis, where many points have been palpated, the surface is ofa first color. In regions 22 and 23, which are less critical for theprosthesis, where less points have been palpated, the surface is of asecond color. For the rest of the femur, in regions 24 where little orno sensing has been performed, the image is substantially that of theinitial model at another scale factor and this is indicated by a thirdcolor. The portion of the surface contained in spheres of X mm aroundthe digitized points may ate be colored. More or less brightly coloredareas are thus obtained according to the amount of sensing. A colorgradation may be assigned according to the increasing values of X toobtain a continuous effect. The values of the inaccuracy of thereconstruction on the surface may be obtained by other means, whatmatters being to given a notion thereof to the surgeon.

When a planar section of the reconstructed surface is displayed,inaccuracy colors may further be displayed on the portions of theintersection contours between, the plane and the surface. Preferably,contours are displayed around the calculated intersection contour with athickness depending all along the contour on the inaccuracy of theestimated surface in the considered region. As illustrated in FIG. 3B,if a point of the intersection contour between the plane and the surfacehas an inaccuracy of X mm, a thickness of X mm is given to the contourof this point.

As illustrated in FIG. 4, it is known to define and construct models ofthe ligamentary structures (also including tendons, muscles, cartilages,and others) attached to the surfaces of the modeled bone structures.Such models are relatively faithful approximations of the reality whichenable predicting the general behavior of the knee structures, accordingto the different positions of the prostheses, as described in article “Astrain-energy model of passive knee kinematics of surgical implantationstrategies” by E. Chen et al, published in Medical Image Computing AndComputer-Assisted Intervention—MICCAI '2000, Spinger-Verlag LNCS Series1935, pages 1086-1095, October 2000. The main difficulty of knownmethods is the construction of the models adapted to each patient. Theattachment points of the ligaments may be located on MRI images but thisis inaccurate and tedious, it does not provide the elastic properties ofthe ligaments, and does not translate the general behavior of the kneeincluding the sum of all unlocaled minor structures. For simplicity, amodel formed of a femur 1 and of a tibia 2 connected together byligaments 31, 32, 33 is considered. For example, the lateral ligaments,the crossed ligaments and the ligaments of the rear capsule may bemodeled by simple straight lines or elastic curves or else by pencils ofstraight lines or curves, with a maximum elongation for each straightline, curve or fiber. Having used the previously-described method todeform the model on the surface points digitized on the real bone, theresult of the deformation may be applied to the attachment points of theIigamentary structures on each bone of the model so that they are nowknown in the reference system associated with each bone. Given thestrong inaccuracies of the models and the strong variations of eachindividual, it would be inaccurate to use the elasticity parameters ofthe ligaments of the model and to apply them as such to the patient'sdata. To avoid such errors, prior to the intervention, once the positionmarks are in place in each bone, the surgeon or another operator exertsmotions on the tibia in all possible directions and for several kneeflexions to reach multiple extreme positions of the tibia with respectto the lemur. The operator exerts strong but reasonable forces on thebones, to place the ligaments close to their maximum elongation. Thecomputer memorizes all the relative positions of the tibia with respectto the femur during these motions. For each ligament connecting a pointA of the femur to a point A′ of the tibia, all the distances betweenpoints A and A′ for each of the memorized relative positions are thencalculated. Only the largest distance is retained. This distance is thatcorresponding to the maximum ligament length. At the end of this step,each ligament model is known by its two attachment points on the lemurand on the tibia, as well as by its maximum length when extended. Basedon the maximum length of the ligament in extended position, and assumingthat the manual strain imposed to the ligament by the surgeon isapproximately known, models known in biomechanics may be applied on theextension of the ligaments to assign them a nonlinear curvecharacterizing the elongation according to the tension strain, but sucha very complete model will have to only remain qualitative and themaximum elongation model will generally be that used. In practice, thesystem according to the present invention includes means for memorizingthe maximum extensions of the ligaments for different angular kneeflexion areas to compensate for the errors linked to the position of theligament attachments in each of these areas, these angular areas may bethe area of a flexion from 0 to 10 °, the area of a flexion from 10 to30°, and the area of a flexion from 70 to 120°. For each area, it isalso possible to only reconstruct the model, of the ligaments which areknown to be involved in this area.

To complete the acquisition of the data necessary for what follows, theposition of the ankle center must be determined in the referentialsystem of the tibia and the hip center must be determined in thereferential system of the femur. For this last point, known methods areused, for example, the method described in French, patent applicationFR-A-278351 by P. Cinqum et ah entitled “Proeede et dispositif dedetermination du centre d'une articulation”. To determine the anklecenter, the present invention provides digitizing characteristic pointson the ankle and defining the ankle center by a geometric rule usingthese characteristic points, as a complement of the data acquired onpreoperative radiographs. For example, the bumps of the internal andexternal malleolae may be palpated, after which the ankle center can beconsidered as the right-hand point with a relative distance equal to therelative distance measured on a front radiograph of the ankle.

The present invention provides using the various above-mentionedmeasurement and position determination means, to determine an idealtheoretical position of femoral and tibial implants, it should be clearthat the sequence of the different steps may be modified in many waysaccording to each surgical technique.

As illustrated in FIGS. 5A to 5C, the position of a portion of theprosthesis on a bone, for example, tibial prosthesis 41, is first set.Said prosthesis is generally formed of a fixed or mobile superiorsurface of a tibia 42, its position is defined by the 3 parametersdefining a section plane and by the 3 parameters defining the positionof the implant in the section plane (2 translations, 1 rotation). Theimplant size must also be chosen from among a wider or narrower range.

To begin with, the tibial prosthesis has a center T mechanically knownby construction of the prosthesis. The tibial prosthesis also has a mainplane which corresponds to the section plane on which it will bear. Itis imposed as a constraint that the straight line crossing prosthesiscenter T and perpendicular to the section plane crosses the center ofankle C. The plane of the tibial prosthesis is then forced to be tangentto spheres centered on ankle center C. This constraint sets 2 of the 6parameters.

Then, a reference point PT is palpated on the tibia and the sectionplane is placed at a distance E from point PT, the value of E beingequal to the thickness of the superior surface of the tibia. Thisconstraint sets 1 of the 6 parameters.

There remains to determine the ideal position of the implant in thesection plane. A horizontal axis of the knee is first determined eitherby searching the rotation axis between the two extreme flexion andextension positions of the knee, or by connecting two specific anatomicpoints such as the epicondyles, defined by direct palpation or definedon the model adjusted to the patient. The angle between this knee axisand the axis of the tibial prosthesis is established by default at 0°.The two remaining translation parameters are set to respect a geometricbulk in each considered section plane.

As illustrated in FIG. 6A, for the smallest given prosthesis size, anarbitrary initial position of the prosthesis is given, and theintersection contours between the surface and the corresponding sectionplane are calculated and compared to the prosthesis contour in thisplane. For each of the two contours, the rectangle of minimum sizeencompassing all the contour points is calculated, imposing anorientation of an edge of the rectangle parallel to horizontal axis AH.The intervals between the edges of each of the two rectangles areminimized, which gives a new position of the prosthesis in the sectionplane, and this process is repeated until it converges. The values of Xand X′ are thus measured between the lateral edges of the prosthesis andthe lateral edges of the contour of the section on the surface, and thelateral position is adjusted to equalize X and X′. Similarly, thedistance from back to front Y is adjusted so that the prosthesis comesat Y mm from the anterior edge of the intersection contour, Y being avalue set by default by the surgeon. The entire process is repeated,searching for the largest size for which all edges of the prosthesis areinside of the edges of the intersection contour, including the posterioredges. The position, the size and the orientation of the tibialprosthesis are thus totally automatically determined. If need be, theoperator may then move each of the parameters, preferably by means of atactile screen (or any other mouse equivalent), to align on values ofhis choice according to each surgical technique recommendation.

The position of the femoral prosthesis is determined in an approximatelyequivalent manner, taking into account center H of the hip instead ofthe ankle center. As illustrated in FIG. 6B, the anteroposteriorposition of the prosthesis is automatically calculated to equalizethickness Ep of the posterior condyle of the prosthesis with distance Dpcalculated between, the posterior section plane of prosthesis PCP andthe most posterior point PP of the surface of one of the two posteriorcondyles of the knee selected by the surgeon. Posterior point PP isautomatically determined by the computer as being the point of thecondyle considered on the model and adapted to the patient having thesmallest coordinate Y in the direction of a vector Y from the posteriorto the anterior. This principle is applicable to the search for all theendmost points in a given direction. The size of the largest prosthesisis determined by the computer so that the distance between the endmostpoint E which is most proximal to the prosthesis is close to the lemursurface while remaining inside of this surface. This criterion isfulfilled by iteratively minimizing the distance between the endmostpoint of the memorized prosthesis and all the triangular facets formingthe surface. The distal position of the prosthesis is determined by thecomputer to equalize the thickness of the distal condyle of prosthesisEp with distance Dp calculated between the distal section plane of theprosthesis and the most distal point of the surface of one of the twodistal condyles of the knee selected by the surgeon.

To adjust the lateral position of the femur prosthesis, the lateraledges may he used as described for the tibia. Preferentially, thepresent invention provides memorizing the trajectory of the midpoint Rof the patella surface in a knee flexion motion, starting with thecomplete extension. A small and light position mark attached on theexternal portion of the patella by means of small thin and shallow pinsis used for this purpose. For a position of patella 8 closed on femur 1(obtained for example at the beginning of the operation), the motions ofthe patella mark with respect to the femur are recorded. Point R thusdescribes a trajectory which is known in the femur reference system. Thefemur prosthesis contains a groove to accommodate the patella during theknee flexion. The middle of the groove is in a plane.

As illustrated in FIG. 6C, the position of the femur prosthesis isdetermined to have the plane of the groove coincide at best with thetrajectory of point R. A rotation parameter may be used to optimize thisalignment. To optimize all criteria at the same time, the process startsfrom an empirically-determined arbitrary initial position close to thesearched solution, then the criteria are minimized one by one bymodifying the value of the position, orientation, or size parameter ofthe prosthesis which influences it most iteratively, until obtaining astable convergence of the ideal position, orientation and size of theimplant. When several parameters influence a criterion, multidimensionaloptimization methods well known in mathematical literature are used.

Up to now, it has been assumed that the positions of the tibia and ofthe femur were independent. In reality, the prostheses of the femur andof the tibia are designed by defining an ideal trajectory of the tibialprosthesis on the femoral prosthesis from flexion to extension, at leastfor 3 or 4 flexion positions, for example, 0°, 30°, 90° and 120°. Foreach of these angles, the ideal relative position between the femoralcomponent and the tibial component of the prosthesis is totallydetermined. Some prostheses are said to be non-congruent and allow formore complex motions than a simple trajectory of flexion of the tibialcomponent with respect to the femoral component, but the average neutralkinematics significantly describe an ideal searched component, it beingalso possible for the method implemented by the present invention totake into account the intervals with respect to the neutral kinematics.At this stage, all the relative positions of the implants and of thebones for different motions chosen according to the consideredprosthesis can thus be simulated. The model then enables predicting thatthe ligaments do not exceed their limiting value for all these relativepositions. If some ligaments exceed their limits, the surgeon may usethis information to provide surgically relaxing the ligament. At anytime, the surgeon can intervene on the ligaments and randomly acquireagain the extreme positions to recalibrate the parameters of theligaments and restart the prediction.

For any global position, the present invention provides simulatingrelative motions of the tibia and of the femur by rotations aroundcontact points existing on the condyles to simulate positions in whichthe ligaments are in maximum elongation when forces approximatelyequivalent in intensity and direction to the forces applied uponmeasurement of the maximum elongations of the ligaments ate applied. Theligamentary balance can thus be predicted for different flexion anglescharacterized by the amplitude of the motions and by the dissymmetry ofthe possible motions around the neutral position.

The surgeon can then freely determine the essential parameters whichmost influence the setting of the ligamentary balance, without havingmade any bone section yet. He can for example choose to keep a perfectalignment of the hip and ankle centers with the prosthesis center inextension, but inclining the line perpendicular to the section planeswith respect to the mechanical axis, thus creating oblique interlinesbetween the prostheses. Any type of surgical technique can thus besimulated by using the system according to the present invention.

Once each section plane of a bone (tibia or femur) has been determined,it is provided to attach to this bone a section guide in which a sawblade is engaged to perform the section with accuracy according to theangle determined by the computer (possibly altered by the surgeon). Asection guide generally includes at least two cylindrical bushesenabling placing threads fixed in the bone. A section guide is arelatively bulky and heavy instrument, and supports adjustable withscrews, wheels or wedges to hold and place these section guidesgenerally have to be used, said supports being themselves attached tothe patient by various rods which are heavy, bulky and often invasive,that is, significantly deteriorating the bone in its healthy parts.Ideally, it would be desired to be able to avoid using such supports andplace the section guides directly, but this is very difficult to performmanually. The direct alignment of a plane on an ideal plane or of asolid on an ideal solid is a delicate operation, even using visualalignments on a screen which shows the real and desired positions ofeach structure according to various graphical representation modes. Thepresent invention, instead of trying to directly position a sectionguide, provides previously using a drilling guide Including twocylindrical bushes having exactly the same spacing as those of thecross-section guide and a punctual point used as a mechanicalconstraint.

FIG. 7 shows a drilling guide according to an embodiment of the presentinvention. This drilling guide includes a handle 51. The two cylindricalbushes are designated by references 52 and 53. To this drilling guide isrigidly associated a position mark 55 visible by the tridimensionalpositioning system monitoring the operation scene. Mark 55 is forexample provided with 3 reflective markers and is Y-shaped. According toa significant feature of the present invention, the drilling guideincludes a pointed point 54. The general shape of this drilling guide,that is, the relative position of point 54 and of bushes 52 and 53 inthe Y-shaped position mark is memorized in the computer used todetermine the position and the orientation of the section plane withrespect to the considered bone. As shown in FIG. 8, this computerdisplays a target including a central target C1 and lateral targets C2and C3. The display of target C1 is a parallel perspective view in thedirection of the point axis. The display of targets C2 and C3 areparallel perspective views in the direction of the bush axis. First, theimage of point 54 must be brought exactly on the center of target C1.The point must for this purpose be slid on the bone surface according totwo translations, which is easy. Once the good position of the point hasbeen found, the point is very slightly driven into the bone so that ifremains stable thereafter. All the guide motions are then forced to turnaround this fixed point. The images of bushes 52 and 53 are then broughton lateral targets C2 and C3, which is easily done by setting threerotations around a fixed and mechanically stable point. These operationsare performed by the surgeon or another operator by displacing thedrilling guide on the bone and by monitoring its image on the computerwhich substantially appears as shown in FIG. 8A. Thus, at the step ofFIG. 8B, point 54 is put in contact with central target 61. At the stepof FIG. 8C, bushes 52 and 53 are brought in front of targets C2 and C3and, at the step of FIG. 8D, the bushes are placed according to theproper vertical orientation. Once the drilling guide is in position,threads inserted in bushes 52 and 53 are fixed in the bone.

FIG. 9 shows an alternative of the drilling guide of FIG. 7 providedwith means for blocking in position to avoid any sliding upon placing ofthe threads in the bone. For this purpose, on handle 51 is assembled ahorizontal frame 61 which carries at its two ends, on either side ofhandle 51, two auxiliary vertical bushes 62 and 63. Bach of bushes 62,63 receives a pointed rod, respectively 64, 65 which crosses this bush.Inside of frame 61 is provided a blocking means operated by a button 67.Such a blocking can be performed by a spring which maintains a pressureon the rods. When the button is pressed, rods 64, 65 freely slide inbushes 62, 63. Thus, they come down until stopping against the boneabove which they are placed. As soon as button 67 is released, the rodsare blocked in position. The surgeon, as soon as he has reached theposition illustrated in FIG. 8D, can then, without having to keep onmonitoring the target appearing on the computer screen, assemble thethreads while being ensured that the drilling guide does remain in itsposition, since it bears upon 3 fixed points.

Once the drilling threads are positioned in the bone, the drilling guideis removed and the first section guide is assembled on the threads whichhave just been set. For a prosthesis such as the femur which includesseveral section planes, a series of section guides calibrated to performall sections corresponding to the bearing planes of the prosthesis,propping up against the two reference threads placed in the bone, maythen be added. For each of these section guides, the relative positionof the two bushes intended to contain the holding threads and thesection planes is precisely known. It is important to note, on thisregard, that the point imposes a degree of liberty of the section guidessince it is in contact with the surface. The choice of the pointposition is thus very important since it conditions the final positionof the prosthesis.

FIG. 10 shows another drilling guide 70 specifically applicable to thefemur prosthesis in which the holding point 71 is off-centered withrespect to the drilling bushes 72, 73, to bear against the anteriorsurface of femur 1, to mechanically force the drilling guide to respectthe anterior position of the prosthesis to be with accuracy.

FIG. 11 shows another drilling guide 80 specifically applicable to thefemur prosthesis in which holding point 81 is off-centered with respectto drilling bushes 82, 83 to bear against the posterior surface of oneof the two condyles of femur 1, to mechanically force the drilling guideto respect the posterior position of the prosthesis to be with accuracy.

Of course, this structure is likely to have various alterations andmodifications which will occur to those skilled in the art. For example,several points and a single blocking rod could be provided. All thedrilling guides described in the present invention will be made inshapes and materials to be as light as possible, to be easily handled.

Once a number of section planes have been formed, wedges can beintroduced between the femur and the tibia bearing against thesesections at the level of the two condyles of the femur to check that theligamentary balance will be correct once the prostheses have beenplaced. Conventionally, the surgeon mechanically displaces the tibiafrom left to right to evaluate its angular play, but this measurementremains inaccurate. The system according to the present inventionenables accurately measuring the angular variation and displaying it onthe computer screen. The two signed angles Bd and Bg obtained by anextreme displacement to the left and to the right with respect to theneutral position of the knee at rest are displayed. The differencebetween the absolute values of the two angles Bd and Bg is a measurementof the Iigamentary imbalance from left to right. The sum of the absolutevalues of angles Bd and Bg is a measurement of the general ligamentarybalance. Indicators Bd+Bg and Bd−Bg are measured and displayed forvarious flexion angles. Preferentially, angles Bd and Bg are graphicallyshown on a screen in a vertical segment of a straight line correspondingto the neutral position and by two segments intersecting the neutralsegment at its vertex and forming angular values of Bd and Bg with theneutral segment. By means of these measurements, the surgeon can extendor relax the ligaments, or add or subtract thicknesses between theprostheses of the femur and of the tibia to obtain a good balance forall degrees of flexion.

According to another preferential embodiment, the present inventionprovides displaying the distances between the closest points feeing oneanother on the femur and on the tibia equipped with their simulated orreal prosthesis, for each of the two condyles, and for several flexionangles, when the knee is submitted to external stress of swinging fromleft to right.

Once the femoral prosthesis is in place, many surgical, techniquesinvite to place a small prosthesis of button type on the internalsurface of the patella. The system according to the present inventionenables determining the ideal position of this patellar button. Theposition of the groove of the femoral prosthesis may be determined inthe position reference system associated with the femur, either by usingthe previously predicted position, or by digitizing in fine the grooveby palpation on the fitted prosthesis. The relative positions of theposition mark, attached to the patella are known and memorized forseveral flexion angles. For a chosen flexion position, the digitizedgroove position can then be displayed, on screen by projecting it on aview corresponding to the internal patella surface. Or conversely, thepatella trajectory obtained for ail flexions can be obtained accordingto an axial or front view of the femur trochlea. After havingconventionally cut the patella across its thickness, the surgeon canthen use a drilling guide and aim at a point on the internal surface ofthe patella which coincides with the groove on the femur, eitherglobally, or for a given angular flexion area, so that the patella doespenetrate at the middle of the groove towards 20 degrees of flexion, andto balance the lateral forces which will be exerted between the patellaand the femoral-prosthesis. This drilling into the bone will then beused as a centering to place the final patellar button.

The method and the system described in the present invention may beapplied to any type of knee prosthesis and they are compatible with mostsurgical knee prosthesis setting techniques, and they may be extended toother joints such as the elbow or the shoulder.

I/We claim:
 1. A computer assisted orthopedic surgery system comprising:a first reference marker attachable to a femur: a second referencemarker attachable to a patella; a tracking device for tracking aposition of the patella attached to the second reference marker withrespect to the femur attached to the first reference marker; a model ofa femur bone that is not specific to a patient's knee joint; a computerconfigured to deform the model of the femur bone in response to thetracking device tracking a sensor that Is moved in proximity of thepatent's knee joint; and a display connected to the computer fordisplaying a planned position of a femoral component on the model of thefemur and the tracked position of the patella relative to the femur. 2.The system of claim 1, wherein the computer is further configured todetermine the planned position based on an optimization of the positionof the femoral component on the model relative to the tracked positionof the patella and relative to the model of the femur bone.
 3. Thesystem of claim 2, wherein the optimization is based on a groove of thefemur coinciding with a motion of the patella.
 4. The system of claim 1,wherein the second reference marker is attachable to an external portionof the patella.
 5. The system of claim 1, wherein the second referencemarker includes small thin and shallow pins for attaching to thepatella.
 6. A computer assisted orthopedic surgery system comprising: afirst reference marker attachable to a femur; a second reference markerattachable to a patella; a tracking device for tracking a trajectory ofthe second reference marker with respect to the first reference marker;a deformable model of a femur bone that is not specific to a patient'sknee joint, wherein the deformable model is obtained by the trackingdevice tracking a sensor that is moved in proximity of the patent's kneejoint; and a display that displays a planned position of a femoralcomponent on the deformable model of the femur and the trackedtrajectory of the second reference maker with respect to the firstreference marker.
 7. The system of claim 6, further comprising acomputer configured to determine the planned position based on anoptimization of the position of the femoral component on the deformablemodel relative to the tracked trajectory and relative to the deformablemodel of the femur bone.
 8. The system of claim 7, wherein theoptimization is based on a groove of the femur coinciding with thetracked trajectory.
 9. The system of claim 6, wherein the secondreference marker is attachable to an external portion of the patella.10. The system of claim 6, wherein the second reference marker includessmall thin and shallow pins for attaching to the patella.